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A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm
Sponsor: AbbVie
Summary
There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.
Official title: A Phase 1 Open-Label Study Evaluating the Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Myeloproliferative Neoplasm Subjects
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
85
Start Date
2019-11-08
Completion Date
2026-12-31
Last Updated
2025-02-14
Healthy Volunteers
No
Conditions
Interventions
Navitoclax
Tablet; Oral
Ruxolitinib
Tablet; Oral
Celecoxib
Capsule; Oral
Locations (42)
City of Hope /ID# 239769
Duarte, California, United States
Providence - St. Jude Medical Center /ID# 242558
Fullerton, California, United States
Moores Cancer Center at UC San Diego /ID# 229584
La Jolla, California, United States
UCLA /Id# 222784
Los Angeles, California, United States
Northwestern University Feinberg School of Medicine /ID# 224203
Chicago, Illinois, United States
Norton Cancer Institute - St. Matthews /ID# 239300
Louisville, Kentucky, United States
Duplicate_Brigitte Harris Cancer Pavilion /ID# 238686
Detroit, Michigan, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 242554
Omaha, Nebraska, United States
Duplicate_East Carolina University Brody School of Medicine /ID# 238560
Greenville, North Carolina, United States
Gabrail Cancer Center Research /ID# 228924
Canton, Ohio, United States
Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550
Gettysburg, Pennsylvania, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 228169
Richmond, Virginia, United States
Cliniques Universitaires UCL Saint-Luc /ID# 225314
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UMHAT Sveti Georgi /ID# 240022
Plovdiv, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 240077
Sofia, Bulgaria
Klinicki bolnicki centar Zagreb /ID# 240140
Zagreb, City of Zagreb, Croatia
Centre Antoine Lacassagne - Nice /ID# 242293
Nice, Alpes-Maritimes, France
CHU Amiens-Picardie Site Sud /ID# 240792
Amiens, Somme, France
AP-HP - Hopital Saint-Louis /ID# 240685
Paris, France
IUCT Oncopole /ID# 242353
Toulouse, France
Universitaetsklinikum Freiburg /ID# 222791
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Klinikum Kassel /ID# 225440
Kassel, Hesse, Germany
Universitaetsmedizin Rostock /ID# 225436
Rostock, Mecklenburg-Vorpommern, Germany
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 224835
Berlin, Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 221408
Rome, Lazio, Italy
ASST Spedali civili di Brescia /ID# 224962
Brescia, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 224071
Meldola, Italy
Shonan Kamakura General Hospital /ID# 224315
Kamakura-shi, Kanagawa, Japan
Kindai University Hospital /ID# 213241
Osakasayama-shi, Osaka, Japan
Osaka University Hospital /ID# 213235
Suita-shi, Osaka, Japan
Juntendo University Hospital /ID# 213255
Bunkyo-ku, Tokyo, Japan
University of Yamanashi Hospital /ID# 229279
Chuo-shi, Yamanashi, Japan
University Clinical Center Serbia /ID# 240674
Belgrade, Beograd, Serbia
Hospital Duran i Reynals /ID# 224007
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra - Pamplona /ID# 224839
Pamplona, Navarre, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 226041
Madrid, Spain
Duplicate_Karolinska University Hospital /ID# 239992
Stockholm, Stockholm County, Sweden
Linkoping University Hospital /ID# 239995
Linköping, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215631
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 215634
Taichung, Taiwan
Dokuz Eylul University Medical Faculty /ID# 239952
Izmir, Turkey (Türkiye)
Gloucestershire Hospitals NHS Foundation Trust /ID# 241189
Cheltenham, Gloucestershire, United Kingdom